EssayShould donors be allowed to give broad consent to future biobank research?
Introduction
Local and national research for genetic risk factors for cancer frequently lack statistical power, and specific traits might be identified when their prevalence in a population or in specific families is merely a confounding factor. Validation of the biological importance of genes thought to be associated with cancer and the identification of previously unknown causes of cancer need analyses of large numbers of familial cases and controls—preferably from multiple populations. International collaboration is needed, but regulations for patient consent that are too strict and discrepancies in national policies on informed consent might hinder progress in cancer research (figure 1).1, 2, 3 Establishment of common ground for review of the ethics of biobank research is essential. Here, we argue that broad consent to multiple purposes of biomedical research and future consent to as yet unspecified biomedical research by donors for use of human blood and tissue samples in future biobank-based research is legitimate.
Section snippets
The conceptual issue
Arguments against allowing broad consent and future consent state that consent should be based on information relevant to an assessment of benefits and risks associated with participation in a research project. Vilhjalmur Arnason argues that “the more general the consent is, the less informed it becomes. It is misleading to use the notion of informed consent for participation in research that is unforeseen and has not been specified in a research protocol”.4 However, this claim raises the
Respect for donors
A further argument against broad consent and future consent states that the practice of giving specific information and asking for specific consent shows respect for patients and donors. This argument would indeed be true if the process of obtaining specific consent did not jeopardise the amount and quality of research that can be done. Since the response for collection of data (eg, sending out questionnaires or asking for renewed consent to use biobank samples obtained previously) from any
The informed and voluntary assumption of risk
An argument against broad consent and future consent is risk exposure. The basic idea of informed consent, emanating from the Nuremberg trials, is that any risk associated with a research protocol must be accepted on a voluntary basis. The need for an informed and voluntary assumption of risk seems to preclude broad consent and future consent. However, if the risk of harm from future biomedical research is low and sufficiently well controlled, if the participant voluntarily accepts this level
Broad consent for future biobank research
Strong arguments for allowing broad consent and future consent include the importance of biobank-related research, respect for the autonomy of donors, and consistency with current practice.
Acknowledgment of the view of actual donors and potential donors
Few studies have investigated the perceptions of actual donors and potential donors regarding the use of broad consent or specific consent to biobank research.19 Interviews20 of 1038 members of a so-called people's panel by the UK human genetics commission suggested that most panel members (ie, four in five) wanted specific consent for every new project on existing samples. In a study21 of 100 healthy volunteers, 35% reported that they wanted to be consulted if their tissue samples were to be
Broad consent and future consent: a scale from specified to blanket consent
Although we argue for broad consent and future consent, we do not suggest a policy where anything goes. If respect for autonomy was the only argument for the need for informed consent, blanket consent permitting any use of a sample would be a logical solution. Our argument against blanket consent is the societal importance of biobank-related biomedical research: blanket consent could lead to the consumption of important samples, potentially allowing commercial, purely technical or political
Withdrawal of consent
We suggest that consent should be regarded as valid until further notice. There should be a realistic opportunity for withdrawal of consent for those who have donated identifiable samples and data, which can be an issue with biobank-based research that can last for many decades (eg, contact information to the biobank might have changed, and donors are unlikely to save contact information for decades).
The Swedish national biobanking programme has established regional biobank registries that act
Broad consent: not broad permissions from ethics-review boards
The option of broad consent and future consent does not imply once-and-for-all permission for broad research proposals by ethics-review boards. For an ethics-review board to assess the risk–benefit relation for a donor, it must review the coding measures, information security, and other potential risks for the donor that might arise from, for example, changes in legal status, principal investigators, or organisation of the original biobank.
Conclusion
Broad consent and consent to future research studies are valid ethically and should be recommended for biobank research, provided that personal information related to the research is handled safely, that donors of biological samples are granted the right to withdraw consent, and that every new study is approved by the ethics-review board; all three criteria must be fulfilled. Giving donors the option of broad consent and future consent facilitates important research and shows respect for the
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Examples from Swedish biobank research
Frequency of major molecular responses to imatinib or interferon alfa plus cytarabine in newly diagnosed chronic myeloid leukemia
N Engl J Med
Inherited susceptibility to breast cancer
Cancer Surv
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